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2026 data FDA MAUDE openFDA FDA Class II

Blood Pressure Cuff

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §870.1120 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Blood Pressure Cuff LIGHT-BOOK · MAUDE

#898 of 1000 · 492 reports · 1992–2026

  • BOOK 492 reports
  • RANK #898 of 1000
  • DEATH 2 death-typed
  • INJ 132 injury-typed
  • MALF 297 malfunction
  • SPAN 1992–2026
  • PEAK 2017: 67
  • PHOTO Enzyme Linked Immunoa…

Nearest event-volume peer: Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (0 report gap)

Blood Pressure Cuff sits #898 of 1000 among tracked device types with 492 MAUDE reports spanning 1992–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports sit below the device-type norm

Blood Pressure Cuff carries 60.4% MALFUNCTION-coded reports, 4.5pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
  • INJ 26.8% corpus 30.3% · below corpus mean (-3.5 pp)
  • MALF 60.4% corpus 64.8% · below corpus mean (-4.5 pp)

Lead product-problem code Material Separation is 19% of coded problems · Lead manufacturer COOK INC accounts for 85% of manufacturer-tagged reports · Top event location I is 36% of location-tagged rows .

Blood Pressure Cuff in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Blood Pressure Cuff carries 492 MAUDE reports, ranked #898 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 297 (60.4%)
Injury 132 (26.8%)
Other 50 (10.2%)
11 (2.2%)
Death 2 (0.4%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

280 (54.5%)
Other 130 (25.3%)
Required Intervention 60 (11.7%)
R 13 (2.5%)
Life Threatening 8 (1.6%)
Hospitalization 7 (1.4%)
L 4 (0.8%)
Disability 4 (0.8%)
O 3 (0.6%)
S 2 (0.4%)
Death 2 (0.4%)
Invalid Data 1 (0.2%)

Top Product Problems

Material Separation 69
Break 39
Reaction 37
Unraveled Material 29
Inflation Problem 24
Leak/Splash 19
Flaked 14
Insufficient Device Problem Information 14
Difficult to Remove 13
Material Fragmentation 13
Adverse Event Without Identified Device or Use Problem 10
Appropriate Device Problem Term/Code Not Available 9
Incorrect, Inadequate or Imprecise Result or Readings 9
Unknown (for use when the device problem is not known) 9
Burst Container or Vessel 8
Material Frayed 8
Output Problem 8
Peeled/Delaminated 8
Unable to Obtain Readings 8
Detachment Of Device Component 7

Yearly Trend

92
1992: 3
93
1993: 3
94
1994: 3
95
1995: 6
96
1996: 2
97
1997: 19
98
1998: 2
99
1999: 4
00
2000: 5
01
2001: 2
02
2002: 36
03
2003: 4
04
2004: 11
06
2006: 2
07
2007: 3
08
2008: 4
09
2009: 2
10
2010: 1
11
2011: 5
12
2012: 7
13
2013: 9
14
2014: 9
15
2015: 23
16
2016: 50
17
2017: 67
18
2018: 44
19
2019: 41
20
2020: 5
21
2021: 12
22
2022: 3
23
2023: 20
24
2024: 15
25
2025: 20
26
2026: 50

Reports in 2025 (20) held close to the prior two-year average of 18.

Related Entities for Blood Pressure Cuff

Top Manufacturers

COOK INC 198
MEDLINE INDUSTRIES, LP 35

Event Locations

I 178 (36.2%)
155 (31.5%)
HOSPITAL 121 (24.6%)
NO INFORMATION 10 (2.0%)
OTHER 8 (1.6%)
INVALID DATA 6 (1.2%)
OUTPATIENT TREATMENT FACILITY 5 (1.0%)
UNKNOWN 4 (0.8%)
NURSING HOME 3 (0.6%)
HOME 1 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.2%)

Compare COOK INC vs MEDLINE INDUSTRIES, LP →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Blood Pressure Cuff: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (492 here).

Enzyme Linked Immunoabsorption Assay 492 Prosthesis, Finger, Constrained, Polymer 492 Angiography/Angioplasty Kit 494 Joint, Knee, External Limb Component 494

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Accessories, Catheter, G-U 2 Accessories, Soft Lens Products 2 Bed, Pediatric Open Hospital 2 Blade 2

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Blood Pressure Cuff are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Blood Pressure Cuff; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.